In addition, nine new drug applications (NDAs, equivalent to Biologics License Application in the USA) were filed for marketing in China. In China, 10 antibody drugs were approved in 2018 including two anti-PD-1 antibodies, Toripalimab and Sintilimab, from Shanghai Junshi Biosciences (Shanghai, China) and Innovent Biologics (Suzhou, China), respectively. Ibalizumab, approved by the FDA and manufactured by WuXi Biologics, is the first commercial antibody product produced in China for the US market. At least 13 antibody drugs were approved by the regulatory authorities for commercialization, which include three calcitonin gene-related peptide (CGRP)/CGRP receptor antibodies, the first camelid single-domain antibody and the first anti-HIV therapeutic antibody (Ibalizumab).
Wang summarized the major achievements of global antibody therapeutics in 2018. 1) and the partners and sponsors of the conference. He welcomed all attendees of the conference and thanked the speakers, moderators, panelists, session chairs, the conference organizing committee, CAS volunteers ( Fig. Fubao Wang, vice president of Sarepta Therapeutics, and a board director of CAS delivered the opening remark. The third annual conference organized by the Chinese Antibody Society (CAS) was held on 7 April 2019 in Cambridge, MA.